JAZZ - Jazz Pharma reports positive Xywav data in neurologic sleep disorder
Jazz Pharmaceuticals (JAZZ) announces positive results from Phase 3 study of Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in adult patients with idiopathic hypersomnia.The study design included a titration and optimization period of up to 14 weeks, a Xywav stable-dose period ((SDP)) of two weeks, followed by a 1:1 randomization to either Xywav or placebo for 2 weeks.Improvement in ESS score with Xywav therapy was observed from a mean of 15.7 (3.77) at study entry to a mean of 6.1 (3.99) at end of SDP.Like ESS, improvement in IHSS score with Xywav therapy was observed from a mean of 31.6 (8.34) at study entry to a mean of 15.3 (8.46) at end of SDP.At the end of withdrawal period, participants who were randomized to placebo (n=59) experienced significant worsening compared to those who continued Xywav treatment (n=56) in ESS scores LS mean difference [95% CI] in change from SDP to
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Jazz Pharma reports positive Xywav data in neurologic sleep disorder